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Wainwright Associates Limited

Description: 

Wainwright Associates provides consultancy to the pharmaceutical, medical device and healthcare industries. We offer a professional and flexible service that is customised to our clients' needs. Our consultancy service includes: Regulatory Affairs, Pharmacovigilance, User TestingMarketing Authorisations and Product Development Planning.

We are able to carry out both short and long term contracts and can provide additional resources for in-house projects or manage new programmes of work for you.

Wainwright Associates' consultants are highly qualified and experienced in most therapeutic areas.  The company handles projects in pharmaceuticals, both small molecule and biological products, medical devices, diagnostics, herbals, nutritional products and cosmetics.  Wainwright Associates has a dedicated in-house team and a solid network of local advisors in over 70 countries of the world.

Services cover all the specific activities listed below. We also provide training on all the listed topics.

Regulatory Submissions
Presubmission meetings & liaison with authorities
Clinical trial authorisations & ethics submissions
Marketing authorisations via centralised, decentralised, mutual recognition and national procedures
Electronic (eCTD) submissions
Licence maintenance: variations, Article 61(3) notifications, change of ownership, change of legal status
Orphan designation
Paediatric investigation plans, deferrals & waivers
Scientific advice procedures
Active substance master files
Environmental risk assessments
Post-approval commitments

Global Regulatory Intelligence
Determination of regulatory requirements worldwide
Local support for national regulatory submissions
Local advisors in over 70 countries
Literature searches

Pharmacovigilance
Clinical trial safety management
Clinical study & post-marketing case processing
Eudravigilance registration and reporting
EU QPPV
PSURs, Annual safety reports,
Strategic advice & inspection preparations
Medical information & scientific service
Risk management plans
Pharmacovigilance System Master Files (PSMF)
Quality management systems

Marketing Authorisation
Searches for new products
Licensing negotiations
Evaluation of opportunities
Location of licensing partners
Technical/regulatory due diligence
Transfer of technology, including identification of contract manufacturers

Product Development Planning
Advice on applicable legislation
Recommendation of best route to market
Borderline issues addressed
Strategic regulatory planning of R&D programmes
Study design & protocol development
Pharmaceutical, non-clinical and clinical consultancy
Assessment of scientific documentation

Medical Device Services
Classification & best route to market
CE Marking
Preparation of technical files, quality manuals & risk assessments

Product Literature
Writing SMPC, label & leaflet texts and design of artwork
User testing
Promotional review and compliance

Audits
GCP, GMP, GLP, GDP
ISO 13485
Pharmacovigilance/device vigilance audits
Supplier audits

Services: 

Contact Information: 

Wainwright Associates Limited
Wessex House, Marlow Road
Bourne End, , SL8 5SP, GBR
Phone : 1628530554
Fax : 1628530559
Internet : www.wainwrightassociates.co.uk
Email : enquiries@wainwrightassociates.co.uk
Contact Person : Jon Jeffery